Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse drug reactions (ADRs) identified during clinical trials and postmarketing experience with paracetamol are listed below by System Organ Class (SOC). The frequencies are defined according to the following convention: 

Very common           ≥ 1/10
Common                ≥ 1/100 and < 1/10

Uncommon              ≥ 1/1,000 and <1/100

Rare                  ≥ 1/10,000 and <1/1,000
Very rare             <1/10,000

Not known             (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence is unavailable, frequency category is listed as 'Not known'.



6/5/24, 4:22 PM       Acamoli forte 50 mg/ml syr strawberry/tutti frutti flavour SK 07-2024 


System Organ Class (SOC)                       Frequency                                 Adverse Drug Reaction (Preferred Term)

Blood and lymphatic system disorders           Not known                                 Blood disorder (including thrombocytopenia and agranulocytosis)1

Immune system disorders                        Very rare                                 Anaphylactic reaction 

Very rare                                 Hypersensitivity

Hepatobiliary disorders                        Not known                                 Liver injury2 
Skin and subcutaneous tissue                   Very rare                                 Rash disorders
Not known                                 Fixed eruption

Not known                                 Rash pruritic

Not known                                 Urticaria
Renal and urinary disorders                    Uncommon                                  Nephropathy toxic 
Not known                                 Renal papillary necrosis3

Investigations                                 Not known                                 Transaminases increased4 
1 Reported following paracetamol use, but not necessarily causally related to the drug 
2 Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year
3 Reported after prolonged administration

4 Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these elevations are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.
Very rare cases of serious skin reactions have been reported.
Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il